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Laser Ablation for Prostate Cancer (TPF-LITT Trial)

Led By Fernando J Bianco, MD
Research Sponsored by Urological Research Network, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prostate volume: ≥ 18 and ≤ 100 cc, measured by MRI
Presence of Intermediate risk prostate cancer with a volume that is less than 1/3 of the gland volume by MRI evaluation
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

TPF-LITT Trial Summary

This trial assesses the safety & tolerance of a new prostate cancer treatment that's done in the office setting under local anesthesia to preserve organ function & reduce surg. risk.

Who is the study for?
Men aged 50-80 with low to intermediate risk prostate cancer, who can consent and follow the study plan. They should have a prostate size of 18-100 cc by ultrasound or MRI, PSA <20 ng/ml, no urinary retention, creatinine levels <2 ng/dl with GFR >45. Excluded are those with neurogenic bladder issues, poor sexual function scores (SHIM score <14), surgery risks like infection or coagulopathy, high post-void residual urine volume (>250 mL), prior prostate cancer treatments or major neurological conditions.Check my eligibility
What is being tested?
The trial tests TRANBERG® TPF-LITT for treating prostate tumors in an office setting under local anesthesia. It aims to preserve organ function while targeting tumor ablation using fusion imaging guidance. The study will evaluate safety and tolerance of this minimally invasive procedure and its effects on urinary and sexual functions as well as MRI changes in the treated area over time.See study design
What are the potential side effects?
Potential side effects may include discomfort from the laser therapy itself, possible impacts on urinary function leading to incontinence issues, changes in sexual function including erectile dysfunction or altered ejaculation following treatment.

TPF-LITT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
My prostate size is between 18 and 100 cc according to an MRI.
My prostate cancer is at an intermediate risk level and occupies less than a third of my prostate.
I do not have problems emptying my bladder completely.
My prostate size is between 18 and 100 cc as measured by ultrasound.
My kidney function is normal, with creatinine levels below 2 ng/dl and GFR above 45.

TPF-LITT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of TRANBERG® TPF-LITT performed in the office setting under local anesthesia.
Secondary outcome measures
Average Ablated area volume (in cc) measured by MRI 1-month following the procedure
Average Ablated area volume (in cc) measured by MRI 1-year following the procedure
Average Ablated area volume (in cc) measured by MRI 3-month following the procedure
+7 more

TPF-LITT Trial Design

1Treatment groups
Experimental Treatment
Group I: TPF-LITT ARMExperimental Treatment1 Intervention
partial gland ablation of the prostate using laser device and imaging fusion

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for urinary incontinence include pelvic floor muscle training, medications, and surgical interventions. Pelvic floor muscle training strengthens the muscles that support the bladder, improving control over urination. Medications such as anticholinergics reduce bladder muscle spasms, while beta-3 agonists relax the bladder muscle to increase storage capacity. Surgical options like sling procedures provide support to the urethra, preventing leakage. These mechanisms are crucial as they target the underlying causes of incontinence, offering relief and improving quality of life. While LITT focuses on ablating cancerous tissue using laser-induced heat, its principle of targeted tissue modification can be conceptually related to surgical interventions in incontinence treatment, where precise anatomical corrections are made to restore function.

Find a Location

Who is running the clinical trial?

Urological Research Network, LLCLead Sponsor
4 Previous Clinical Trials
10,170 Total Patients Enrolled
Fernando J Bianco, MDPrincipal InvestigatorUrological Research Network
1 Previous Clinical Trials
150 Total Patients Enrolled
Isabel H Lopez, BS., MBAStudy DirectorUrological Research Network

Media Library

TRANBERG® Transperineal Fusion Laser--Induced Thermal Therapy of Prostate Cancer (TPF-LITT) (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05698576 — N/A
Urinary Incontinence Research Study Groups: TPF-LITT ARM
Urinary Incontinence Clinical Trial 2023: TRANBERG® Transperineal Fusion Laser--Induced Thermal Therapy of Prostate Cancer (TPF-LITT) Highlights & Side Effects. Trial Name: NCT05698576 — N/A
TRANBERG® Transperineal Fusion Laser--Induced Thermal Therapy of Prostate Cancer (TPF-LITT) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05698576 — N/A
~6 spots leftby Jun 2025